Biorisk management and management systems

Context

Regulations require that companies and institutions set measures to control personnel exposure to pathogenic organisms and limit, prevent or manage the release of biological agents in the community or the environment. Some are more specific and require the development of an integrated biosafety programme (''biosafety concept'' in some countries). But even when such a requirement is not always specified explicitly, the fact that biosafety is imbedded in core activities and that it involves a variety of aspects makes it necessary to organise preventive and protective measures in a structured and integrated manner.

One way of organising a number of various measures efficiently is using management systems. More and more institutions have implemented or plan to develop such systems, using standards like the ISO 9000 series and others for quality, ISO 14001 for environmental management or OHSAS 18001 for occupational safety. The more recent CWA 15793 (2011) on Laboratory Biorisk Management, which is the first internationally recognised reference document that specifically addresses the management of biological hazards, allows the same approach in the field of biosafety and biosecurity. Besides integrating these two aspects, CWA 15793 presents the advantage of being fully compatible with the other management standards.

Services

The services we provide with respect to biorisk management range from specific technical guidance to the complete development and implementation of an adapted concept.

Our general approach with respect to biorisk management is to develop compliant, effective and sustainable programmes:

• compliant through a diligent and pro-active reading of applicable regulations
• effective thanks to a risk-based and pragmatic analysis that takes into account the specifics of the concerned activities
• sustainable through a management system-based approach.

While designing the programme we make sure it is fully integrated into or compatible with existing or possible future management systems. We use CWA 15793 either as a simple guidance for designing the programme or as a stand-alone standard allowing possible future certification. We also ensure a full ownership of the programme by the organisation.

Typically, the setting of a biorisk management programme includes a review of the activities and practices, the proposal of an overall concept, the development of the programme and its implementation. For this last step, our mission is to help the company or institution to implement their programme in providing training, advice and further technical assistance.